Observational Safety Evaluation of Asenapine (OBSERVA)

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An observational post-authorisation safety specialist cohort event monitoring (SCEM) study to monitor the safety and utilisation of asenapine (Sycrest®) in the mental health trust setting.

The OBSERVA study is an observational study designed to monitor the safety and drug utilisation of asenapine (Sycrest®). This novel atypical antipsychotic was recently authorised for use in the European Union by the European Medicines Agency, following which the post-marketing OBSERVA study was requested in order to evaluate the short term safety of this drug.

The OBSERVA study hopes to gain additional information on possible adverse events in users of asenapine by including large numbers of patients in a routine clinical practice setting. The study aims to recruit 1000 patients started on asenapine in the mental health trust setting over a two year data collection period. Any patient in England will be eligible for inclusion after the clinical decision to prescribe asenapine has been made as part of normal clinical practice.

Patient recruitment to the OBSERVA study has now ended.

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